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Id Subject Object Predicate Lexical cue
T1 0-202 Sentence denotes Safety and efficacy assessment of allogeneic human dental pulp stem cells to treat patients with severe COVID-19: structured summary of a study protocol for a randomized controlled trial (Phase I / II).
T1 0-202 Sentence denotes Safety and efficacy assessment of allogeneic human dental pulp stem cells to treat patients with severe COVID-19: structured summary of a study protocol for a randomized controlled trial (Phase I / II).
T2 203-214 Sentence denotes OBJECTIVES:
T2 203-214 Sentence denotes OBJECTIVES:
T3 215-359 Sentence denotes To assess the safety and therapeutic effects of allogeneic human dental pulp stem cells (DPSCs) in treating severe pneumonia caused by COVID-19.
T3 215-359 Sentence denotes To assess the safety and therapeutic effects of allogeneic human dental pulp stem cells (DPSCs) in treating severe pneumonia caused by COVID-19.
T4 360-373 Sentence denotes TRIAL DESIGN:
T4 360-373 Sentence denotes TRIAL DESIGN:
T5 374-497 Sentence denotes This is a single centre, two arm ratio 1:1, triple blinded, randomized, placebo-controlled, parallel group, clinical trial.
T5 374-497 Sentence denotes This is a single centre, two arm ratio 1:1, triple blinded, randomized, placebo-controlled, parallel group, clinical trial.
T6 498-511 Sentence denotes PARTICIPANTS:
T6 498-511 Sentence denotes PARTICIPANTS:
T7 512-609 Sentence denotes Twenty serious COVID-19 cases will be enrolled in the trial from April 6th to December 31st 2020.
T7 512-609 Sentence denotes Twenty serious COVID-19 cases will be enrolled in the trial from April 6th to December 31st 2020.
T8 610-721 Sentence denotes INCLUSION CRITERIA: hospitalised patients at Renmin Hospital of Wuhan University satisfy all criteria as below:
T8 610-721 Sentence denotes INCLUSION CRITERIA: hospitalised patients at Renmin Hospital of Wuhan University satisfy all criteria as below:
T9 722-1191 Sentence denotes 1)Adults aged 18-65 years;2)Voluntarily participate in this clinical trial and sign the "informed consent form" or have consent from a legal representative.3)Diagnosed with severe pneumonia of COVID-19: nucleic acid test SARS-CoV-2 positive; respiratory distress (respiratory rate > 30 times / min); hypoxia (resting oxygen saturation < 93% or arterial partial pressure of oxygen / oxygen concentration < 300 mmHg).4)COVID-19 featured lung lesions in chest X-ray image.
T9 722-1191 Sentence denotes 1)Adults aged 18-65 years;2)Voluntarily participate in this clinical trial and sign the "informed consent form" or have consent from a legal representative.3)Diagnosed with severe pneumonia of COVID-19: nucleic acid test SARS-CoV-2 positive; respiratory distress (respiratory rate > 30 times / min); hypoxia (resting oxygen saturation < 93% or arterial partial pressure of oxygen / oxygen concentration < 300 mmHg).4)COVID-19 featured lung lesions in chest X-ray image.
T10 1192-1211 Sentence denotes EXCLUSION CRITERIA:
T10 1192-1211 Sentence denotes EXCLUSION CRITERIA:
T11 1212-1296 Sentence denotes Patients will be excluded from the study if they meet any of the following criteria.
T11 1212-1296 Sentence denotes Patients will be excluded from the study if they meet any of the following criteria.
T12 1297-2220 Sentence denotes 1.Patients have received other experimental treatment for COVID-19 within the last 30 days;2.Patients have severe liver condition (e.g., Child Pugh score >=C or AST> 5 times of the upper limit);3.Patients with severe renal insufficiency (estimated glomerular filtration rate <=30mL / min/1.73 m2) or patients receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis;4.Patients who are co-infected with HIV, hepatitis B, tuberculosis, influenza virus, adenovirus or other respiratory infection viruses;5.Female patients who have no sexual protection in the last 30 days prior to the screening assessment;6.Pregnant or lactating women or women using estrogen contraception;7.Patients who are planning to become pregnant during the study period or within 6 months after the end of the study period;8.Other conditions that the researchers consider not suitable for participating in this clinical trial.
T12 1297-2220 Sentence denotes 1.Patients have received other experimental treatment for COVID-19 within the last 30 days;2.Patients have severe liver condition (e.g., Child Pugh score >=C or AST> 5 times of the upper limit);3.Patients with severe renal insufficiency (estimated glomerular filtration rate <=30mL / min/1.73 m2) or patients receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis;4.Patients who are co-infected with HIV, hepatitis B, tuberculosis, influenza virus, adenovirus or other respiratory infection viruses;5.Female patients who have no sexual protection in the last 30 days prior to the screening assessment;6.Pregnant or lactating women or women using estrogen contraception;7.Patients who are planning to become pregnant during the study period or within 6 months after the end of the study period;8.Other conditions that the researchers consider not suitable for participating in this clinical trial.
T13 2221-2249 Sentence denotes INTERVENTION AND COMPARATOR:
T13 2221-2249 Sentence denotes INTERVENTION AND COMPARATOR:
T14 2250-2307 Sentence denotes There will be two study groups: experimental and control.
T14 2250-2307 Sentence denotes There will be two study groups: experimental and control.
T15 2308-2371 Sentence denotes Both will receive all necessary routine treatment for COVID-19.
T15 2308-2371 Sentence denotes Both will receive all necessary routine treatment for COVID-19.
T16 2372-2619 Sentence denotes The experimental group will receive an intravenous injection of dental pulp stem cells suspension (3.0x107 human DPSCs in 30ml saline solution) on day 1, 4 and 7; The control group will receive an equal amount of saline (placebo) on the same days.
T16 2372-2619 Sentence denotes The experimental group will receive an intravenous injection of dental pulp stem cells suspension (3.0x107 human DPSCs in 30ml saline solution) on day 1, 4 and 7; The control group will receive an equal amount of saline (placebo) on the same days.
T17 2620-2765 Sentence denotes Clinical and laboratory observations will be performed for analysis during a period of 28 days for each case since the commencement of the study.
T17 2620-2765 Sentence denotes Clinical and laboratory observations will be performed for analysis during a period of 28 days for each case since the commencement of the study.
T18 2766-2780 Sentence denotes MAIN OUTCOMES:
T18 2766-2780 Sentence denotes MAIN OUTCOMES:
T19 2781-2783 Sentence denotes 1.
T19 2781-2783 Sentence denotes 1.
T20 2784-2859 Sentence denotes Primary outcome The primary outcome is Time To Clinical Improvement (TTCI).
T20 2784-2859 Sentence denotes Primary outcome The primary outcome is Time To Clinical Improvement (TTCI).
T21 2860-3099 Sentence denotes By definition, TTCI is the time (days) it takes to downgrade two levels from the following six ordered grades [(grade 1) discharge to (grade 6) death] in the clinical state of admission to the start of study treatments (hDPSCs or placebo).
T21 2860-3099 Sentence denotes By definition, TTCI is the time (days) it takes to downgrade two levels from the following six ordered grades [(grade 1) discharge to (grade 6) death] in the clinical state of admission to the start of study treatments (hDPSCs or placebo).
T22 3100-3132 Sentence denotes Six grades of ordered variables:
T22 3100-3132 Sentence denotes Six grades of ordered variables:
T23 3133-3477 Sentence denotes GradeDescriptionGrade 1:Discharged of patient;Grade 2:Hospitalized without oxygen supplement;Grade 3:Hospitalized, oxygen supplement is required, but NIV / HFNC is not required;Grade 4:Hospitalized in intensive care unit, and NIV / HFNC treatment is required;Grade 5:Hospitalized in intensive care unit, requiring ECMO and/or IMV;Grade 6:Death.
T23 3133-3477 Sentence denotes GradeDescriptionGrade 1:Discharged of patient;Grade 2:Hospitalized without oxygen supplement;Grade 3:Hospitalized, oxygen supplement is required, but NIV / HFNC is not required;Grade 4:Hospitalized in intensive care unit, and NIV / HFNC treatment is required;Grade 5:Hospitalized in intensive care unit, requiring ECMO and/or IMV;Grade 6:Death.
T24 3478-3604 Sentence denotes ABBREVIATIONS: NIV, non-invasive mechanical ventilation; HFNC, high-flow nasal catheter; IMV, invasive mechanical ventilation.
T24 3478-3604 Sentence denotes ABBREVIATIONS: NIV, non-invasive mechanical ventilation; HFNC, high-flow nasal catheter; IMV, invasive mechanical ventilation.
T25 3605-3607 Sentence denotes 2.
T25 3605-3607 Sentence denotes 2.
T26 3608-3723 Sentence denotes Secondary outcomes 2.1 vital signs: heart rate, blood pressure (systolic blood pressure, diastolic blood pressure).
T26 3608-3723 Sentence denotes Secondary outcomes 2.1 vital signs: heart rate, blood pressure (systolic blood pressure, diastolic blood pressure).
T27 3724-3920 Sentence denotes During the screening period, hospitalization every day (additional time points of D1, D4, D7 30min before injection, 2h ± 30min, 24h ± 30min after the injection) and follow-up period D90 ± 3 days.
T27 3724-3920 Sentence denotes During the screening period, hospitalization every day (additional time points of D1, D4, D7 30min before injection, 2h ± 30min, 24h ± 30min after the injection) and follow-up period D90 ± 3 days.
T28 3921-4157 Sentence denotes 2.2 Laboratory examinations: during the screening period, 30 minutes before D1, D4, D7 infusion, 2h ± 30min, 24h ± 30min after the end of infusion, D10, D14, D28 during hospitalization or discharge day and follow-up period D90 ± 3 days.
T28 3921-4157 Sentence denotes 2.2 Laboratory examinations: during the screening period, 30 minutes before D1, D4, D7 infusion, 2h ± 30min, 24h ± 30min after the end of infusion, D10, D14, D28 during hospitalization or discharge day and follow-up period D90 ± 3 days.
T29 4158-5327 Sentence denotes 2.3 Blood routine: white blood cells, neutrophils, lymphocytes, monocytes, eosinophils, basophils, neutrophils, lymphocytes, monocytes, eosinophils Acidic granulocyte count, basophil count, red blood cell, hemoglobin, hematocrit, average volume of red blood cells, average red blood cell Hb content, average red blood cell Hb concentration, RDW standard deviation, RDW coefficient of variation, platelet count, platelet specific platelet average Volume, platelet distribution width,% of large platelets; 2.4 Liver and kidney function tests: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, γ-glutamyl transferase, prealbumin, total protein, albumin, globulin, white / globule ratio , Total bilirubin, direct bilirubin, cholinesterase, urea, creatinine, total carbon dioxide, uric acid glucose, potassium, sodium, chlorine, calcium, corrected calcium, magnesium, phosphorus, calcium and phosphorus product, anion gap, penetration Pressure, total cholesterol, triacylglycerol, high density lipoprotein cholesterol, Low density lipoprotein cholesterol, lipoprotein a, creatine kinase, lactate dehydrogenase, estimated glomerular filtration rate.
T29 4158-5327 Sentence denotes 2.3 Blood routine: white blood cells, neutrophils, lymphocytes, monocytes, eosinophils, basophils, neutrophils, lymphocytes, monocytes, eosinophils Acidic granulocyte count, basophil count, red blood cell, hemoglobin, hematocrit, average volume of red blood cells, average red blood cell Hb content, average red blood cell Hb concentration, RDW standard deviation, RDW coefficient of variation, platelet count, platelet specific platelet average Volume, platelet distribution width,% of large platelets; 2.4 Liver and kidney function tests: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, γ-glutamyl transferase, prealbumin, total protein, albumin, globulin, white / globule ratio , Total bilirubin, direct bilirubin, cholinesterase, urea, creatinine, total carbon dioxide, uric acid glucose, potassium, sodium, chlorine, calcium, corrected calcium, magnesium, phosphorus, calcium and phosphorus product, anion gap, penetration Pressure, total cholesterol, triacylglycerol, high density lipoprotein cholesterol, Low density lipoprotein cholesterol, lipoprotein a, creatine kinase, lactate dehydrogenase, estimated glomerular filtration rate.
T30 5328-5444 Sentence denotes 2.5 Inflammation indicators: hypersensitive C-reactive protein, serum amyloid (SAA); 2.6 Infectious disease testing:
T30 5328-5444 Sentence denotes 2.5 Inflammation indicators: hypersensitive C-reactive protein, serum amyloid (SAA); 2.6 Infectious disease testing:
T31 5445-5668 Sentence denotes Hepatitis B (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb), Hepatitis C (Anti-HCV), AIDS (HIVcombin), syphilis (Anti-TP), cytomegalovirus CMV-IgM, cytomegalovirus CMV-IgG; only during the screening period and follow-up period D90 ± 3.
T31 5445-5668 Sentence denotes Hepatitis B (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb), Hepatitis C (Anti-HCV), AIDS (HIVcombin), syphilis (Anti-TP), cytomegalovirus CMV-IgM, cytomegalovirus CMV-IgG; only during the screening period and follow-up period D90 ± 3.
T32 5669-5695 Sentence denotes 2.7 Immunological testing:
T32 5669-5695 Sentence denotes 2.7 Immunological testing:
T33 5696-5847 Sentence denotes Collect peripheral blood to detect the phenotype of T lymphocyte, B lymphocyte, natural killer cell, Macrophage and neutrophil by using flow cytometry.
T33 5696-5847 Sentence denotes Collect peripheral blood to detect the phenotype of T lymphocyte, B lymphocyte, natural killer cell, Macrophage and neutrophil by using flow cytometry.
T34 5848-5951 Sentence denotes Collect peripheral blood to detect the gene profile of mononuclear cells by using single-cell analyses.
T34 5848-5951 Sentence denotes Collect peripheral blood to detect the gene profile of mononuclear cells by using single-cell analyses.
T35 5952-6024 Sentence denotes Collect peripheral blood serum to detect various immunoglobulin changes:
T35 5952-6024 Sentence denotes Collect peripheral blood serum to detect various immunoglobulin changes:
T36 6025-6198 Sentence denotes IgA, IgG, IgM, total IgE; Collect peripheral blood serum to explore the changes of cytokines, Th1 cytokines (IL-1 β, IL-2, TNF-a, ITN-γ), Th2 cytokines (IL-4, IL-6, IL -10).
T36 6025-6198 Sentence denotes IgA, IgG, IgM, total IgE; Collect peripheral blood serum to explore the changes of cytokines, Th1 cytokines (IL-1 β, IL-2, TNF-a, ITN-γ), Th2 cytokines (IL-4, IL-6, IL -10).
T37 6199-6335 Sentence denotes 2.8 Pregnancy test: blood β-HCG, female subjects before menopause are examined during the screening period and follow-up period D90 ± 3.
T37 6199-6335 Sentence denotes 2.8 Pregnancy test: blood β-HCG, female subjects before menopause are examined during the screening period and follow-up period D90 ± 3.
T38 6336-6888 Sentence denotes 2.9 Urine routine: color, clarity, urine sugar, bilirubin, ketone bodies, specific gravity, pH, urobilinogen, nitrite, protein, occult blood, leukocyte enzymes, red blood cells, white blood cells, epithelial cells, non-squamous epithelial cells , Transparent cast, pathological cast, crystal, fungus; 2.10 Stool Routine: color, traits, white blood cells, red blood cells, fat globules, eggs of parasites, fungi, occult blood (chemical method), occult blood (immune method), transferrin (2h ± 30min after the injection and not detected after discharge).
T38 6336-6888 Sentence denotes 2.9 Urine routine: color, clarity, urine sugar, bilirubin, ketone bodies, specific gravity, pH, urobilinogen, nitrite, protein, occult blood, leukocyte enzymes, red blood cells, white blood cells, epithelial cells, non-squamous epithelial cells , Transparent cast, pathological cast, crystal, fungus; 2.10 Stool Routine: color, traits, white blood cells, red blood cells, fat globules, eggs of parasites, fungi, occult blood (chemical method), occult blood (immune method), transferrin (2h ± 30min after the injection and not detected after discharge).
T39 6889-6903 Sentence denotes RANDOMIZATION:
T39 6889-6903 Sentence denotes RANDOMIZATION:
T40 6904-7025 Sentence denotes Block randomization method will be applied by computer to allocate the participants into experimental and control groups.
T40 6904-7025 Sentence denotes Block randomization method will be applied by computer to allocate the participants into experimental and control groups.
T41 7026-7050 Sentence denotes The random ratio is 1:1.
T41 7026-7050 Sentence denotes The random ratio is 1:1.
T42 7051-7070 Sentence denotes BLINDING (MASKING):
T42 7051-7070 Sentence denotes BLINDING (MASKING):
T43 7071-7247 Sentence denotes Participants, outcomes assessors and investigators (including personnel in laboratory and imaging department who issue the sample report or image observations) will be blinded.
T43 7071-7247 Sentence denotes Participants, outcomes assessors and investigators (including personnel in laboratory and imaging department who issue the sample report or image observations) will be blinded.
T44 7248-7356 Sentence denotes Injections of cell suspension and saline will be coded in accordance with the patient's randomisation group.
T44 7248-7356 Sentence denotes Injections of cell suspension and saline will be coded in accordance with the patient's randomisation group.
T45 7357-7475 Sentence denotes The blind strategy is kept by an investigator who does not deliver the medical care or assess primary outcome results.
T45 7357-7475 Sentence denotes The blind strategy is kept by an investigator who does not deliver the medical care or assess primary outcome results.
T46 7476-7515 Sentence denotes NUMBERS TO BE RANDOMIZED (SAMPLE SIZE):
T46 7476-7515 Sentence denotes NUMBERS TO BE RANDOMIZED (SAMPLE SIZE):
T47 7516-7609 Sentence denotes Twenty participants will be randomized to the experimental and control groups (10 per group).
T47 7516-7609 Sentence denotes Twenty participants will be randomized to the experimental and control groups (10 per group).
T48 7610-7623 Sentence denotes TRIAL STATUS:
T48 7610-7623 Sentence denotes TRIAL STATUS:
T49 7624-7702 Sentence denotes Protocol version number, hDPSC-CoVID-2019-02-2020 Version 2.0, March 13, 2020.
T49 7624-7702 Sentence denotes Protocol version number, hDPSC-CoVID-2019-02-2020 Version 2.0, March 13, 2020.
T50 7703-7842 Sentence denotes Patients screening commenced on 16th April and an estimated date of the recruitment of the final participants will be around end of July. .
T50 7703-7842 Sentence denotes Patients screening commenced on 16th April and an estimated date of the recruitment of the final participants will be around end of July. .
T51 7843-7862 Sentence denotes TRIAL REGISTRATION:
T51 7843-7862 Sentence denotes TRIAL REGISTRATION:
T52 7863-7876 Sentence denotes Registration:
T52 7863-7876 Sentence denotes Registration:
T53 7877-7918 Sentence denotes World Health Organization Trial Registry:
T53 7877-7918 Sentence denotes World Health Organization Trial Registry:
T54 7919-7951 Sentence denotes ChiCTR2000031319; March 27,2020.
T54 7919-7951 Sentence denotes ChiCTR2000031319; March 27,2020.
T55 7952-8073 Sentence denotes ClinicalTrials.gov Identifier: NCT04336254; April 7, 2020 Other Study ID Numbers: hDPSC-CoVID-2019-02-2020 FULL PROTOCOL:
T55 7952-8073 Sentence denotes ClinicalTrials.gov Identifier: NCT04336254; April 7, 2020 Other Study ID Numbers: hDPSC-CoVID-2019-02-2020 FULL PROTOCOL:
T56 8074-8182 Sentence denotes The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).
T56 8074-8182 Sentence denotes The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).
T57 8183-8363 Sentence denotes In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
T57 8183-8363 Sentence denotes In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.